None listed
Conditions
Brief summary
A Phase II study of efficacy and safety of Pegasys® in patients with chronic myeloid leukaemia (CML) in complete or near complete cytogenetic remission but persisting molecular positivity at 600 mg or maximum tolerated dose of Glivec Patients with Ph+ve CML with complete or near complete cytogenetic responses to Glivec® at 600 mg or maximum tolerated dose, but with persisting molecular positivity. Primary Objective: To assess whether adding Pegasys® to Glivec® in these patients improves molecular response status (by PCR quantification of bcr-abl transcripts)
Interventions
To establish whether the addition of the long activing interferon Pegasys is both safe and can improve molecular remission status in CML patients in good remission on Glivec.
Sponsors
Australasian Leukaemia and Lymphoma Group
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
Inclusion criteria
All of the following criteria must be met: Cohort One: 1. Chronic Myeloid Leukemia with Philadelphia chromosome translocation or bcr-abl transcript at diagnosis; 2. Treated with Glivec®, as a single agent at 600 mg or maximum tolerated dose for at least 6 months; 3. Achieved complete cytogenetic response on Glivec® therapy AND not previously in accelerated phase or blast crisis; 4. Sustained complete cytogenetic response for at least 6 months, confirmed by bone marrow studies at screening visit for this study; 5. No past toxicity higher than Grade III related to high dose (>6MU/d) alpha- interferon therapy. No post toxicity higher than Grade II related to low dose (3MU/day or less) alpha-interferon therapy; 6. Persisting detectable bcr/abl transcripts by Q-PCR. 7. Patients must have adequate renal function i.e creatinine < 2 xULN 8. Adequate hepatic function, with serum bilirubin, AST and ALT each < 2 x the upper limit of their normal range (ULN) at the laboratory where the analyses were performed. Cohort Two: 1. Chronic Myeloid Leukemia with Philadelphia chromosome translocation or bcr-abl transcript at diagnosis; 2. Treated with Glivec®, as a single agent at 600 mg or maximum tolerated dose for at least 6 months; 3. Achieved near complete cytogenetic response on Glivec® therapy OR Achieved a complete cytogenetic response on Glivec® therapy AND previously in accelerated phase or blast crisis; 4. Sustained complete or near-complete cytogenetic response for at least 6 months, confirmed by bone marrow studies at screening visit for this study; 5. No past toxicity higher than Grade III related to high dose (>6MU/d) alpha-interferon therapy. No post toxicity higher than Grade II related to low dose (3MU/day or less) alpha-interferon therapy; 6. Persisting detectable bcr/abl transcripts by Q-PCR. 7. Patients must have adequate renal function i.e creatinine < 2 xULN 8. Adequate hepatic function, with serum bilirubin, AST and ALT each < 2 x the upper limit of their normal range (ULN) at the laboratory where the analyses were performed;
Outcome results
None listed